Binghamton University Human Subjects Research Review
APPLICATION FOR WAIVER OF HIPAA AUTHORIZATION

[This form is to be used in conjunction with the Application for HSRRC Review]

Title of Study:

The HIPAA Privacy Standard at 45 CFR 164.512(i) requires that certain criteria be met in order to grant a waiver of individual authorization for research uses of Protected Health Information (PHI). In addition to these criteria, the federal Common Rule (45 CFR 46 section 116(d)) stipulates that “whenever appropriate, the subjects will be provided with additional pertinent information after participation.”

This request is for:

TOTAL WAIVER

When you request a total waiver of the HIPAA Authorization, you are requesting permission to access, use or disclose a research subject’s PHI for your research study without seeking the subject specific authorization for that use or disclosure.

PARTIAL WAIVER

When a partial waiver is requested, you may request that certain required elements of the HIPAA authorization be altered or that the HIPAA authorization be waived for a portion of the study. [For instance, you may request a waiver for subject identification or recruitment purposes but not for enrollment purposes. For example, you may request a waiver of the HIPAA authorization requirement so that a treating physician may obtain verbal permission from the patient/parent so that the physician can notify the study coordinator of the patient’s/parent’s interest in the study. Once the study coordinator has discussed the study with the interested patient and parent, they will consent the participant and parent and obtain a full authorization.]

Please specify what you are requesting the waiver (total or partial) for:

Please respond to every question on this application. Incomplete applications will be returned, and will result in a delay of your study being reviewed.

  1. Does the use or disclosure of PHI involve no more than a minimal risk to the privacy

of the individual based on at least the presence of the following:

  1. An adequate plan to protect the identifiers from improper use and disclosure.
  2. An adequate plan to destroy identifiers at the earliest opportunity consistent with the conduct of the research unless there is a health or research justification for retaining the identifiers or as otherwise required by law.
  3. Adequate written assurances that the protected health information will not be reused or disclosed to another person or entity, except as required by law, for authorized oversight of the research study, or other research for which the use or disclosure of PHI would be permitted.

YESNO

2. Describe the plan to protect the identifiers (names, addresses, telephone numbers, social security numbers, medical record numbers, photos, and other identifying information etc.) from improper use and disclosure?

3. Describe the plan to destroy the identifiers at the earliest opportunity, or provide

justification for retaining the identifiers?

4.Will a waiver adversely affect the privacy rights of the individual?

YES NO

5.Could the research be practicably done without the waiver?

YES NO

If “no” justify:

6. Could the research practicably be done without access to, use or disclosure of the

PHI identified below?

YES NO

Please identify the PHI that will be used under this waiver request.

7.Are the privacy risks to individuals who’s PHI will be used or disclosed reasonable in relation to the anticipated benefit, if any, to the individuals? (Please describe your risk/benefit analysis relating to the waiver request below.)

YES NO

Describe:

  1. By signing this form, I assure that the protected health information will not be

reused or disclosed to another person or entity, except as required by law, for

authorized oversight of the research study, or other research for which the use or

disclosure of PHI would be permitted.

If all of these criteria are met, the IRB may grant a waiver of authorization. The HSRRC’s action will be documented and communicated to the Principal Investigator.

Will the Principal Investigator be the only member of the research team who will access, use or disclose PHI?

YES NO

If no, please name all of the individuals who will have access to PHI during the research study, including students.

Name / Job Description/Role on Study

INVESTIGATORS AGREEMENT:

As Principal Investigator of this study, I assure the Office for Human Subjects Protection that the following statements are true:

The information that is provided in this form is true and accurate. I will seek and obtain prior written approval from the HSRRC for any substantive modifications to the proposal, including but not limited to, changes in procedures and co-investigators.

I will report in writing any significant new findings that develop during the course of this study that may affect the risks and benefits to the individuals whose PHI is being obtained.

I will not begin my research, including subject identification or recruitment, until I have received written notification of HSRRC approval. I will comply with all HSRRC requests to report on the status of the study.

I will not reuse or disclose any PHI to any other person or entity, except as required by law, for the authorized oversight of research or for other permitted research.

I will conduct the research in compliance with all applicable federal and state laws and regulations and Binghamton University’s policies governing human subject research.

Signature of Principal InvestigatorDate

FACULTY SPONSOR AGREEMENT:

Student Research (i.e., research done by graduate students, residents, or fellows) requires the approval of a Binghamton University Faculty Supervisor. As a Supervisor to the Student Investigator, I assume responsibility for ensuring that the Student complies with all applicable federal and state laws and regulations and Binghamton University’s Policy and Procedures governing human subject research.

Check here if not applicable.

Advisor’s Name:
Department:
Address:
Telephone Number:
E-mail:
Original Signature of Advisor:
Date:
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